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FDA 510(k)

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

K-Number: K260397 · 2026-04-06

ApplicantHironic Co., Ltd.
Decision Date2026-04-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under approval number K260397. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K260397.

When was SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) approved by the FDA?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) received FDA 510(k) clearance on 2026-04-06, under approval number K260397.

What company makes SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is manufactured by Hironic Co., Ltd..

What is the FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

The FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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